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Evolution of Dark Ideas When Introducing or Switching an Antidepressant (DEPASSE)

Primary Purpose

Current Major Depressive Disorder

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
DEPASSE Apllication
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Current Major Depressive Disorder focused on measuring Aged between 18 and 65, Major depressive disorder, Suicide, Ecological momentary assessment, Smartphone application

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Subject aged 18 to 65
  • Diagnosis of a characterized depressive episode assessed by the clinician
  • Depression score : MADRS> 20
  • Introduction or switch of an antidepressant (without combination of molecules)
  • Signed informed consent
  • Able to understand the nature, purpose and methodology of the study
  • French language
  • Able to understand and conduct clinical assessments.

Exclusion criteria:

  • The following psychiatric comorbidities: Bipolar disorder, schizophrenia, alcohol dependence and / or any other substance objectivized during the clinical evaluation
  • Patient presenting a depressive episode characterized with mixed component, psychotic, melancholic or catatonic characteristics
  • Score MADRS greater than or equal to 5 to one of the items
  • Subject protected by law (guardianship or curatorship)
  • Subject in exclusion period from another protocol
  • Subject not affiliated to, or not beneficiary of, a social security scheme
  • Pregnant orbreastfeeding patient

Sites / Locations

  • Uhmontpellier

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

depressed patients

Arm Description

All patients performed the same evaluation : ecological momentary assesement throught smartphone and 3 sheduled visits. All patients are depressed patients.

Outcomes

Primary Outcome Measures

Values of dark ideas assessed with a Likert type scale [1;5]
Evolution of dark ideas over 30 days. Throught the DEPASSE smartphone application, the patient assess the actual frequency of dark ideas from a Likert type scale of 1 (= not at all) to 5 (= often)

Secondary Outcome Measures

Values of the actual mood assessed with a Lickert type scale [1;5]
Evolution of the mood over 30 days. Throught the DEPASSE smartphone application, the patient evaluates whether he/she is in a good mood from 1 (= not at all) to 5 (= absolutely)
Values of the actual motivation assessed with a Lickert type scale [1;5]
Evolution of the mood over 30 days. Throught the DEPASSE smartphone application, the patient evaluates his/her motivation from 1 (= not at all) to 5 (= absolutely)
Values of the ability to feel pleasure as usual assessed with a Lickert type scale [1;5]
Evolution of the mood over 30 days. Throught the DEPASSE smartphone application, the patient evaluates his/her the ability to feel pleasure as usual from 1 (= not at all) to 5 (= absolutely)
Values of the energy assessed with a Lickert type scale [1;5]
Evolution of the mood over 30 days. Throught the DEPASSE smartphone application, the patient evaluates whether he/she feels energetic from 1 (= not at all) to 5 (= absolutely)
Values of the social activities assessed with a Lickert type scale [1;5]
Evolution of the mood over 30 days. Throught the DEPASSE smartphone application, the patient assesses whether he or she is involved in social activities from 1 (= not at all) to 5 (= absolutely)
Values of the concentration assessed with a Lickert type scale [1;5]
Evolution of the mood over 30 days. Throught the DEPASSE smartphone application, the patient assesses his/her ability to concentrate as usual from 1 (= not at all) to 5 (= absolutely)
Values of the stress assessed with a Lickert type scale [1;5]
Evolution of the mood over 30 days. Throught the DEPASSE smartphone application, the patient assesses whether he feels relaxed from 1 (= not at all) to 5 (= absolutely)
Values of the libido assessed with a Lickert type scale [1;5]
Evolution of the mood over 30 days. Throught the DEPASSE smartphone application, if the patient has the same libido as usual from 1 (= not at all) to 5 (= absolutely)
Values of sleep assessed with a Lickert type scale [1;5]
Evolution of the mood over 30 days. Throught the DEPASSE smartphone application, if the patient sleep well from 1 (= not at all) to 5 (= absolutely)
Score at the Montgomery-Åsberg Depression Rating Scale (MADRS)
Link between the self evaluation of the patient and the evaluation conducted by the psychiatrist
Score at the Columbia Suicide Severity Rating Scale (CSSRS)
Link between the self evaluation of the patient and the evaluation conducted by the psychiatrist
Number of emergency room visits
Link between the evolution of dark ideas over 1 month and the number of emergency room visits
Number of hospitalizations
Link between the evolution of dark ideas over 1 month and the number hospitalizations
Satisfaction score on the Lickert type scale [1;5]
Assessment of the patient satisfaction regarding the utilization of DEPASSE, from 1 (= not at all) to 5 (= absolutely)

Full Information

First Posted
October 27, 2017
Last Updated
December 29, 2020
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT03327974
Brief Title
Evolution of Dark Ideas When Introducing or Switching an Antidepressant
Acronym
DEPASSE
Official Title
Evolution of Dark Ideas When Introducing or Switching an Antidepressant: Hetero-evaluation and Use of a Smartphone Application in the Monitoring of Depression
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Terminated
Why Stopped
Problem on the app, questioned the feasability of the study
Study Start Date
November 24, 2017 (Actual)
Primary Completion Date
December 14, 2018 (Actual)
Study Completion Date
April 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Depression is a frequent disease and a serious public health problem, of which suicide is the most severe complication. Its treatment is based on the introduction of antidepressant which not only proposes a significant delay in the relief of symptoms but also by the phenomenon of lifting of inhibition can increase the suicidal risk during the initiation phase. Therefore there is a major interest in proposing a monitoring of these dark and suicidal ideas, immediately after the implementation of such treatment as well as other symptoms of depression. Thus, the aim of this study is to identify the mechanisms underlying this increase in dark and suicidal ideas in this context.
Detailed Description
The study propose to assess, with an ecological momentary assessment method, the evolution of black ideas over 30 days following the introduction or switch of an oral antidepressants. 103 patients will be recruited suffering from a current major depressive disorder in the Montpellier University Hospital. Each patient will attend a total of 3 scheduled visits, which will be completed over a period of 1 month (inclusion, between 10-15 days, 1 month. During this month, the patient will have to complete daily assesments throught a smartphone application "Depasse". This Servier application allows the daily monitoring of symptoms allowing a regular evaluation, in the form of smileys simulating a Likert type scale evaluation of 1 to 5. 10 parameters are evaluated: moral, black thoughts, sleep, stress, concentration, social activities, energy, pleasure, motivation and libido. Note that when the patient expresses dark thoughts, he is then asked if he wants to hurt himself. If he answers yes, he is then asked to contact an emergency service. One of its originalities is the addition of positive psychology approaches with a positive reinforcement of this evaluation through reward by a smiley in a smiley box and obtaining a "pleasant" image for motivation and incentive. There is the possibility to have the graphical follow-up of the various parameters and to send them by mail to his treating psychiatrist. Advice adapted to the mood of the day is provided taking into account the "dysfunctional" parameters. Similarly, the emergency buoy tool provides access to emergency numbers and directs the patient to seek care. Intelligence of the weight and the treatments established. The app also has a notification setting to remind the patient to evaluate themselves daily.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Current Major Depressive Disorder
Keywords
Aged between 18 and 65, Major depressive disorder, Suicide, Ecological momentary assessment, Smartphone application

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
depressed patients
Arm Type
Other
Arm Description
All patients performed the same evaluation : ecological momentary assesement throught smartphone and 3 sheduled visits. All patients are depressed patients.
Intervention Type
Other
Intervention Name(s)
DEPASSE Apllication
Intervention Description
Application DEPASSE in depressed patients. This application was developed by the laboratory SERVIER, by a scientific committee of psychologists and psychiatrists: Pr. Courtet, Dr Rimlinger and Pr. Swendsen. Depasse is available for all on the App store and on Googleplay. This application has several interests: - The first is the daily monitoring of the symptoms allowing a regular evaluation throught smileys simulating a scale from 1 to 5. The 10 parameters evaluated are: mood, dark ideas, sleep, stress, concentration, social activities, energy, pleasure, motivation and libido. There is the possibility to generate a graph representing the evolution of these parameters. Tips adapted to the actual mood are provided related to the "dysfunctional" parameters.
Primary Outcome Measure Information:
Title
Values of dark ideas assessed with a Likert type scale [1;5]
Description
Evolution of dark ideas over 30 days. Throught the DEPASSE smartphone application, the patient assess the actual frequency of dark ideas from a Likert type scale of 1 (= not at all) to 5 (= often)
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Values of the actual mood assessed with a Lickert type scale [1;5]
Description
Evolution of the mood over 30 days. Throught the DEPASSE smartphone application, the patient evaluates whether he/she is in a good mood from 1 (= not at all) to 5 (= absolutely)
Time Frame
1 month
Title
Values of the actual motivation assessed with a Lickert type scale [1;5]
Description
Evolution of the mood over 30 days. Throught the DEPASSE smartphone application, the patient evaluates his/her motivation from 1 (= not at all) to 5 (= absolutely)
Time Frame
1 month
Title
Values of the ability to feel pleasure as usual assessed with a Lickert type scale [1;5]
Description
Evolution of the mood over 30 days. Throught the DEPASSE smartphone application, the patient evaluates his/her the ability to feel pleasure as usual from 1 (= not at all) to 5 (= absolutely)
Time Frame
1 month
Title
Values of the energy assessed with a Lickert type scale [1;5]
Description
Evolution of the mood over 30 days. Throught the DEPASSE smartphone application, the patient evaluates whether he/she feels energetic from 1 (= not at all) to 5 (= absolutely)
Time Frame
1 month
Title
Values of the social activities assessed with a Lickert type scale [1;5]
Description
Evolution of the mood over 30 days. Throught the DEPASSE smartphone application, the patient assesses whether he or she is involved in social activities from 1 (= not at all) to 5 (= absolutely)
Time Frame
1 month
Title
Values of the concentration assessed with a Lickert type scale [1;5]
Description
Evolution of the mood over 30 days. Throught the DEPASSE smartphone application, the patient assesses his/her ability to concentrate as usual from 1 (= not at all) to 5 (= absolutely)
Time Frame
1 month
Title
Values of the stress assessed with a Lickert type scale [1;5]
Description
Evolution of the mood over 30 days. Throught the DEPASSE smartphone application, the patient assesses whether he feels relaxed from 1 (= not at all) to 5 (= absolutely)
Time Frame
1 month
Title
Values of the libido assessed with a Lickert type scale [1;5]
Description
Evolution of the mood over 30 days. Throught the DEPASSE smartphone application, if the patient has the same libido as usual from 1 (= not at all) to 5 (= absolutely)
Time Frame
1 month
Title
Values of sleep assessed with a Lickert type scale [1;5]
Description
Evolution of the mood over 30 days. Throught the DEPASSE smartphone application, if the patient sleep well from 1 (= not at all) to 5 (= absolutely)
Time Frame
1 month
Title
Score at the Montgomery-Åsberg Depression Rating Scale (MADRS)
Description
Link between the self evaluation of the patient and the evaluation conducted by the psychiatrist
Time Frame
1 month
Title
Score at the Columbia Suicide Severity Rating Scale (CSSRS)
Description
Link between the self evaluation of the patient and the evaluation conducted by the psychiatrist
Time Frame
1 month
Title
Number of emergency room visits
Description
Link between the evolution of dark ideas over 1 month and the number of emergency room visits
Time Frame
1 month
Title
Number of hospitalizations
Description
Link between the evolution of dark ideas over 1 month and the number hospitalizations
Time Frame
1 month
Title
Satisfaction score on the Lickert type scale [1;5]
Description
Assessment of the patient satisfaction regarding the utilization of DEPASSE, from 1 (= not at all) to 5 (= absolutely)
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Subject aged 18 to 65 Diagnosis of a characterized depressive episode assessed by the clinician Depression score : MADRS> 20 Introduction or switch of an antidepressant (without combination of molecules) Signed informed consent Able to understand the nature, purpose and methodology of the study French language Able to understand and conduct clinical assessments. Exclusion criteria: The following psychiatric comorbidities: Bipolar disorder, schizophrenia, alcohol dependence and / or any other substance objectivized during the clinical evaluation Patient presenting a depressive episode characterized with mixed component, psychotic, melancholic or catatonic characteristics Score MADRS greater than or equal to 5 to one of the items Subject protected by law (guardianship or curatorship) Subject in exclusion period from another protocol Subject not affiliated to, or not beneficiary of, a social security scheme Pregnant orbreastfeeding patient
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucile VILLAIN, MD
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uhmontpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
NC

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Evolution of Dark Ideas When Introducing or Switching an Antidepressant

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